BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY

    MDR report key: 2963723 · Received February 15, 2013

    Report

    Report Number
    2029046-2013-00016
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS USED DURING THE PROCEDURE: CARTO 3 SYSTEM MODEL #: M-4800-01 SERIAL #: (B)(4). COOL FLOW IRRIGATION PUMP MODEL #: M-5491-02 SERIAL #:(B)(4). STOCKERT RF GENERATOR MODEL #:M-5463-01 SERIAL #: (B)(4). UNKNOWN ULS CATHETER (BRAND/ MANUFACTURER IS UNKNOWN) (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY THE CALLER THAT THERE WAS A PATIENT INJURY DURING AN AFIB PROCEDURE. THE PATIENT DEVELOPED CARDIAC TAMPONADE. A PERICARDIAL CENTESIS WAS PERFORMED IN WHICH 2500 + CC WERE REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT WAS THEN TRANSFERRED TO THE OPERATING ROOM FOR SURGICAL REPAIR OF THE PERFORATION. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. FURTHERMORE, AN IRRIGATION TEST WAS PERFORMED AND THE CATHETER PASSED, NO OCCLUSION WAS OBSERVED. A COOL FLOW PUMP TEST WAS PERFORMED AS WELL AND THE CATHETER PASSED SPECIFICATIONS. THE CATHETER WAS ALSO EVALUATED FOR EEPROM, CARTO 3, 4 KHZ AND CALIBRATION FUNCTIONALITY. THE CATHETER WAS RECOGNIZED BY CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. EEPROM DATA DEMONSTRATES THE CATHETER WAS PROPERLY CALIBRATED DURING MANUFACTURING. FINALLY, A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE CARDIAC TAMPONADE REMAINS UNKNOWN. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE PATIENT DEVELOPED CARDIAC TAMPONADE. A PERICARDIALCENTESIS WAS PERFORMED IN WHICH MORE THAN 2500CC OF BLOOD WAS REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT WAS THEN TRANSFERRED TO THE OPERATING ROOM FOR SURGICAL REPAIR OF THE PERFORATION. MULTIPLE ATTEMPTS WERE DONE TO REQUEST FOR FURTHER DETAILS OF THE EVENT AND THE PATIENT'S UPDATED HEALTH STATUS, HOWEVER NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68511 NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC (IRWINDALE) D-1266-01-S 15695842M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R